NCT06329674已完成3 期
Evaluate the Efficacy and Safety of the Combination of A51R3 and AJU-A51 Compared With the Combination of A51R3 and A51R2 in Patients With Type 2 Diabetes Mellitus
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 235
- 试验地点
- 1
- 主要终点
- Changes in HbA1c
研究概览
简要总结
A multicenter, randomized, double-blind, parallel group, placebo-controlled, phase 3 study to evaluate the efficacy and safety of the combination of A51R3 and AJU-A51 compared with the combination of A51R3 and A51R2 in patients with Type 2 diabetes mellitus who have inadequate glycemic control with the combination of A51R3 and A51R2
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Those who voluntarily signed the informed consent to participate in this study.
- •Adults aged 19-75 years.
- •Those diagnosed with type 2 diabetes mellitus.
- •7% ≤ HbA1c ≤ 10.5%
- •FPG ≤ 270 mg/dL
- •BMI ≤ 40 kg/㎡
- •Subjects able to understand the study, comply with study procedures, and attend all scheduled visits.
排除标准
- •Those who suffered from acute or chronic metabolic acidosis, lactic acidosis and diabetic ketoacidosis.
- •Those who had genetic disorders such as galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption.
- •Those with heart failure (NYHA class II~IV) or who had suffered from heart failure.
- •Those with a history of malignant tumor within 5 years
- •Those who have a clinically significant liver disease
- •Those who have a clinically significant renal disease
- •SBP > 180 mmHg or DBP > 110 mmHg
- •Those who had allergic reaction to main ingredients or components of the investigational products.
- •Patients planning to become pregnant or of childbearing potential, but not using any recognized contraceptive method
- •Females who are pregnant or breastfeeding.
- •AST or ALT ≥ LRN*3
- •TG ≥ 500 mg/dL
研究组 & 干预措施
AJU-A51+A51R2 placebo+A51R3
Experimental
干预措施: A51R3 (Drug)
AJU-A51+A51R2 placebo+A51R3
Experimental
干预措施: AJU-A51 (Drug)
AJU-A51+A51R2 placebo+A51R3
Experimental
干预措施: A51R2 Placebo (Drug)
AJU-A51 placebo+A51R2+A51R3
Experimental
干预措施: A51R2 (Drug)
AJU-A51 placebo+A51R2+A51R3
Experimental
干预措施: A51R3 (Drug)
AJU-A51 placebo+A51R2+A51R3
Experimental
干预措施: AJU-A51 Placebo (Drug)
结局指标
主要结局
Changes in HbA1c
时间窗: 24th week
Changes in HbA1c at the 24th week after the administration of investigational products from the baseline
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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